Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (ExteNET)

May 17, 2021 updated by: Puma Biotechnology, Inc.

A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer

The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2840

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Sydney, New South Wales, Australia, 2145
        • Sydney West Cancer Trials Centre
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Iron Cancer Care South Brisbane
    • South Australia
      • Adelaide, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
      • Kurralta Park, South Australia, Australia, 5037
        • Ashford Cancer Centre Research
      • North Adelaide, South Australia, Australia, 5006
        • North Adelaide Oncology Calvary Hospital North Adelaide
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Royal Melbourne Hospital
      • Melbourne, Victoria, Australia, 3050
        • The Western Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Hollywood Private Hospital
      • Nassau, Bahamas, 13932
        • Affinity Research Limited
      • Aalst, Belgium, 9300
        • OLVZ Medische Oncologie
      • Brugge, Belgium, 8000
        • AZ. St. Jan
      • Bruxelles, Belgium, 1070
        • Cliniques Universitaires de Bruxelles
      • Hasselt, Belgium, 3500
        • VZW Jesseziekenhuis - Campus Virga Jesse
      • Ieper, Belgium, 8900
        • Jan Yperman ziekenhuis
      • Kortrijk, Belgium, 8500
        • AZ Groeninge ampus Maria's Voorzienigheid (MV) Oncologisch Centrum
      • Liege, Belgium, 4000
        • Centre Hospitalier Regional De La Citadelle
      • Liège, Belgium, 4000
        • CHU de Liège - Domaine Universitaire du Sart Tilman
      • Mons, Belgium, 7000
        • C.H.U. Ambroise Pare
      • Oostende, Belgium, 8400
        • AZ Damiaan - Site Sint-Jozef
      • Ronse, Belgium, 9600
        • AZ Zusters Van Barmhartigheid
      • Sint Niklaas, Belgium, 9100
        • AZ Nikolaas
      • Turnhout, Belgium, 2300
        • Sint-Elisabethziekenhuis
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
        • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
      • Plovdiv, Bulgaria, 4004
        • District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Ist
      • Plovdiv, Bulgaria, 4004
        • District Dispensary for Oncology Diseases Internal Unit- Plovdiv EOOD, Second
      • Sofia, Bulgaria, 1233
        • District Dispensary for Oncology Diseases Internal Unit- Sofia EOOD
      • Sofia, Bulgaria, 1756
        • Specialised Hospital of Active Treatment in Oncology
      • Varna, Bulgaria, 9000
        • Interdistrict Dispensary for Oncology Diseases
      • Quebec, Canada, G1S 4L8
        • Centre Hospitalier Affilie Universitaire de Quebec Hopital du St-Sacrement
      • Quebec, Canada, G6V 3Z1
        • CSSS Alphonse-Desjardins
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
      • Lethbridge, Alberta, Canada, T1J 1W5
        • Jack Ady Cancer Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • CancerCare Manitoba
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Stronach Regional cancer Centre at Southlake
      • Oshawa, Ontario, Canada, L1G 2B9
        • R.S. McLaughlin Durham Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network, Princess Margaret Hospital
      • Weston, Ontario, Canada, M9N 1N8
        • Humber River Regional Hospital - Church Street Site
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
        • Hôpital du Sacré-Coeur de Montréal
      • Montreal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve Rosemont
      • Montreal, Quebec, Canada, H2L 4M1
        • C.H.U.M. - Hopital Notre-Dame, Departement d'Oncologie
      • Beijing, China, 100021
        • Cancer Hospital, Chinese Academy of Medical Sciences
      • Beijing, China, 100032
        • Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
      • Beijing, China, 100071
        • The Hospital Affiliated Academy Military Medical Science, Chinese People's
      • Beijing, China, 100853
        • Chinese People's Liberation Army General Hospital
      • Guangzhou, China, 510060
        • Sun Yat-Sen University Cancer Center
      • Guangzhou, China, 510515
        • Southern Medical University Nanfang Hospital
      • Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center
      • Tianjin, China, 300060
        • Tianjin Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Bogota, Colombia
        • Administradora Country S.A-Clinica del Country
    • Cordoba
      • Monteria, Cordoba, Colombia
        • Oncomedica S.A. IMAT
    • Risaralda
      • Pereira, Risaralda, Colombia
        • Oncologos del Occidente
      • Osijek, Croatia, 31000
        • University Hospital Centre Osijek, Department of Radiotherapy and Oncology
      • Varazdin, Croatia, 42000
        • General Hospital Varazdin
      • Zagreb, Croatia, 10000
        • University Hospital Center Zagreb
      • Zagreb, Croatia, 10000
        • Klinicki bolnicki centar "Sestre Milosrdnice"
      • Brno, Czechia, 625 00
        • Fakultni Nemocnice Brno
      • Brno, Czechia, 65653
        • Masarykuv onkologicky ustav
      • Jihlava, Czechia, 58633
        • Nemocnice Jihlava
      • Nova Ves pod Plesi, Czechia, 26204
        • Institut Onkologie a Reahabilitace na Plesi
      • Pardubice, Czechia, 53003
        • Multiscan s. r. o.
      • Praha, Czechia, 15006
        • Fakultni nemocnice v Motole
      • Aalborg, Denmark, 9000
        • Aalborg Sygehus
      • Aarhus C, Denmark, 8000
        • Aarhus University Hospital
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Esbjerg, Denmark, 6700
        • Sydvestjysk Sygehus
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Hillerod, Denmark, 3400
        • Hillerod Hospital
      • Naestved, Denmark, 4700
        • Næstved Sygehus
      • Odense C, Denmark, 5000
        • Odense Universitetshospital
      • Roskilde, Denmark, 4000
        • Roskilde University Hospital
      • Sonderborg, Denmark, 6400
        • Sygehus Sonderjylland
      • Vejle, Denmark, 7100
        • Vejle Sygehus
      • Viborg, Denmark, 8800
        • Regionshospital Viborg
      • Bordeaux, Cedex, France, 33000
        • C.H.U. De Bordeaux Saint Andre
      • Caen, France, 14076
        • Centre Francois Baclesse
      • Clermont-Ferrand, France, 63011
        • Centre Hospitalier de Montlucon
      • Dijon, France, 21034
        • Centre Georges François Leclerc
      • Grenoble, France, 38043
        • Oncologie department, Hopital albert Michalon
      • Le Chesnay, France, 78157
        • Hopital de Versailles
      • Lille, France, 59020
        • Centre OSCAR LAMBRET
      • Paris, France, 75248
        • Institut Curie, Departement d'Oncologie Medicale
      • Paris Cedex 10, France, 75475
        • Hôpital Saint Louis
      • Paris cedex 13, France, 75651
        • Hôpital La Pitié-Salpêtrière
      • Perigueux, France, 24000
        • Service d'Oncologie et de Radiotherapie, Polyclinique Francheville, 38
      • Rouen, Cedex 1, France, 76038
        • Centre Henri Becquerel
      • Saint Priest en Jarez, France, 42470
        • Institute de Cancerologie de la Loire
      • Saint-Nazaire, France, 44600
        • Pôle Hospitalier Mutualiste
      • Strasbourg, France, 67091
        • CHU Strasbourg
      • Strasbourg, France, 67010
        • Clinique Sainte Anne Centre de Radiothérapie
      • Tours, France, 37044
        • CHU Bretonneau Centre Henry Kaplan
      • Villejuif, France, 94800
        • Institut Gustave Roussy
      • Villejuif, France, 94804
        • CHU Paul Brousse
    • Cedex
      • Saint Herblain, Cedex, France, 44805
        • Centre Rene Gauducheau
      • Aachen, Germany, 52066
        • Marienhospital
      • Augsburg, Germany, 86150
        • Onkologische Praxis
      • Bamberg, Germany, 96049
        • Sozialstiftung Bamberg Klinik fuer Haematologie und internistische Onkologie
      • Berlin, Germany, 10317
        • Onkologische Schwerpunktpraxis
      • Berlin, Germany, 10367
        • Praxisklinik Krebsheilkunde fuer Frauen
      • Berlin, Germany, 10707
        • Onkologische Schwerpunktpraxis
      • Berlin, Germany, 14169
        • Frauenarzt-Zentrum-Zehlendorf
      • Duesseldorf, Germany, 40225
        • Universitaetsklinikum Duesseldorf, Frauenklinik
      • Duesseldorf, Germany, 40235
        • Luisenkrankenhaus
      • Düsseldorf, Germany, 40225
        • Universitaetsklinikum Duesseldorf
      • Erfurt, Germany, 99084
        • Facharzt fuer Frauenheilkunde und Geburtshilfe
      • Frankfurt am Main, Germany, 60389
        • Onkologische Gemeinschaftspraxis Frankfurt
      • Frankfurt am Main, Germany, 60590
        • Frauenklinik der J.W. Goethe-Universitaet
      • Frankfurt am Main, Germany, 65929
        • Staedtische Kliniken Frankfurt am Main-Hoechst Frauenklinik
      • Freiburg, Germany, 79106
        • Praxis für interdisziplinaere Onkologie & Haematologie GbR
      • Georgsmarienhuette, Germany, 49124
        • Klinikum St. Georg/Franziskus, Abteilung fuer Senologie
      • Hameln, Germany, 31785
        • Kreiskrankenhaus Hameln, Onkologische Ambulanz
      • Hannover, Germany, 30177
        • Facharzt fuer Frauenheilkunde
      • Heidelberg, Germany, 69120
        • Nationales Centrum fuer Tumorerkrankungen
      • Heidelberg, Germany, 69115
        • Onkologische Schwerpunktpraxis
      • Kempten, Germany, 87439
        • Klinikum Kempten - Oberallgaeu
      • Kiel, Germany, 24103
        • MTV Abts & Partner Kiel
      • Luebeck, Germany, 23538
        • Universitaetsfrauenklinikum Schleswig-Holstein
      • Magdeburg, Germany, 39108
        • Universitaetsklinikum Magdeburg A.oe.R.
      • Mainz, Germany, 55131
        • Klinikum der Johannes-Gutenberg-Universitaet
      • Muenchen, Germany, 80335
        • Fachpraxis fuer Innere Medizin
      • Muenchen, Germany, 80337
        • Klinik und Poliklinik fuer
      • Muenchen, Germany, 81925
        • Praxis Gynaekologie Arabella Muenchen
      • Offenbach, Germany, 63069
        • Klinik fuer Gynaekologie und Geburtshilfe
      • Oldenburg, Germany, 26121
        • Pius-Hospital Oldenburg
      • Oldenburg, Germany, 26133
        • Klinikum Oldenburg GmbH
      • Recklinghausen, Germany, 45657
        • Oncologianova GmbH
      • Tuebingen, Germany, 72076
        • Universitaetsfrauenklinik Tuebingen
      • Vechta, Germany, 49377
        • St. Marienhospital Vechta
      • Westerstede, Germany, 26655
        • Gemeinschaftspraxis fuer Haematologie und Onkologie
      • Wiesbaden, Germany, 65199
        • Klinik für Gynaekologie und gyn. Onkologie
      • Witten, Germany, 58452
        • Marienhospital Witten
      • Alexandroúpoli, Greece, 68100
        • University General Hospital of Alexandroupoli, Department of Medical Oncology
      • Athens, Greece, 11527
        • Hippokratio General Hospital of Athens
      • Athens, Greece, 11527
        • Hippokration Hospital Athens
      • Larissa, Greece, 41110
        • University General Hospital of Larissa
      • Rio Patras, Greece, 26500
        • University Hospital of Patras
      • Thessaloniki, Greece, 54645
        • Euromedica General Clinic
    • Creete
      • Heraklion, Creete, Greece, 71110
        • University Hospital of Heraklion
    • Crete
      • Chania, Crete, Greece, 73300
        • General Hospital of Chania Ag. Georgios
      • Hong Kong, Hong Kong
        • Department of Clinical Oncology, Tuen Mun Hospital
      • Hong Kong, Hong Kong
        • Queen Mary Hospital, Department of Clinical Oncology, Professorial Block
      • Hong Kong, Hong Kong
        • Queen Mary Hospital, Department of Medicine, Blk K
      • Hong Kong, Hong Kong
        • Queen Mary Hospital, Department of Medicine
    • Wanchai
      • Hong Kong, Wanchai, Hong Kong
        • UNIMED Medical Institute, Comprehensive Centre for Breast Diseases
      • Budapest, Hungary, 1082
        • Semmelweis Egyetem Radiologiai és Onkoterapias Klinika
      • Budapest, Hungary, 1115
        • Fovarosi Onkormanyzat Szent Imre Korhaz
      • Budapest, Hungary, 1122
        • Országos Onkológiai Intézet "B" Belgyogyaszati osztaly
      • Gyula, Hungary, 5700
        • Bekes M. Kepviselotest. Pandy Kalman Korhaz, Megyei Onkol. Kp., Klin. Onkol. es Sugartherapias Oszt.
      • Kaposvar, Hungary, 7400
        • Kaposi Mor Oktato Korhaz, Onkologiai Centrum
      • Kecskemet, Hungary, 6000
        • Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont
      • Miskolc, Hungary, 3526
        • Borsod-Abauj-Zemplen M. Korhaz es Egyetemi Okt. K., Klin. Onk., Sugarterapias es Kozp. Szuro Centrum
      • Nyiregyhaza, Hungary, 4400
        • Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft. / Onkoradiologiai Osztaly
      • Veszprem, Hungary, 8200
        • Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.
      • Beer Sheva, Israel, 84101
        • Soroka University MC, Department of Oncology
      • Haifa, Israel, 31096
        • Rambam Health Care Campus, Oncology Institute
      • Rehovot, Israel, 76100
        • Kaplan Medical Center, Department of Oncology
      • Tel Hashomer, Israel, 52621
        • Sheba Medical Center, Oncology Institute Tel Hashomer
      • Avellino, Italy, 83100
        • Azienda Ospedaliera San Giuseppe Moscati
      • Brindisi, Italy, 72100
        • Presidio Ospedaliero di Summa - Antonio Perrino
      • Catania, Italy, 95123
        • Azienda Ospedaliera Universitaria "Policlinico Vittorio Emanuele"
      • Catanzaro, Italy, 88100
        • Fondazione per la Ricerca e la Cura dei Tumori Tommaso Campanella
      • Monza, Italy, 20052
        • Azienda Ospedaliera San Gerardo
      • Napoli, Italy, 80131
        • Fondazione Giovanni Pascale
      • Napoli, Italy, 80131
        • Unita' Operativa Complessa Oncologia Medica, A.O.R.N. "Cardarelli"
      • Orbassano (TO), Italy, 10043
        • Azienda Ospedaliera San Luigi Gonzaga
      • Padova, Italy, 35131
        • IRCCS Istituto Oncologico Veneto di Padova
      • Pisa, Italy, 56126
        • Azienda Ospedaliero-Universitaria Pisana
      • Reggio Calabria, Italy, 89124
        • Azienda Ospedaliera Bianchi Melacrino Morelli
      • Roma, Italy, 00128
        • Università Campus Bio-Medico
      • Roma, Italy, 00144
        • Oncologia Medica A, Istituti Fisioterapici Ospitalieri
      • Roma, Italy, 00189
        • Ospedale San Pietro Fatebenefratelli
      • Sora (FR), Italy, 03039
        • Ospedale SS Trinità
      • Terni, Italy, 05100
        • Azienda Ospedaliera S. Maria
      • Treviglio, BG, Italy, 24047
        • Ospedale Treviglio e Caravaggio, UO Oncologia Medica
      • Viagrande (CT), Italy, 95029
        • Istituto Oncologico del Mediterraneo
      • Viterbo, Italy, 01100
        • Ospedale Belcolle Viterbo
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center
      • Chiba, Japan, 260-8717
        • Chiba Cancer Center
      • Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
      • Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Fukuoka, Japan, 830-0013
        • Kurume Daiichi Social Insurance Hospital
      • Hiroshima, Japan, 730-8518
        • Hiroshima City Hospital
      • Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
      • Hyogo, Japan, 673-8558
        • Hyogo Cancer Center
      • Kagoshima, Japan, 892-0833
        • Hakuaikai Medical Corporation Sagara Hospital
      • Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Kanagawa, Japan, 241-0815
        • Kanagawa Cancer Center
      • Kumamoto, Japan, 862-8505
        • Kumamoto Municipal Hospital
      • Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital 2-15-3
      • Osaka, Japan, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Osaka, Japan, 565-0871
        • Osaka University Hospital
      • Osaka, Japan, 537-8511
        • Osaka Medical Center for Cancer and Cardiovascular Diseases
      • Saitama, Japan, 362-0806
        • Saitama Cancer Center
      • Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
      • Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
      • Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hp
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
      • Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center, Center for Breast Cancer
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital, Department of Internal Medicine
      • Seoul, Korea, Republic of, 136-705
        • Korea University Anam Hospital, Department of Oncology/Hematology
    • Korea
      • Seoul, Korea, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Kaunas, Lithuania, LT-50161
        • The Hospital of Lithuanian University of Health Sciences Kauno klinikos Oncology and Haematology Clinic
      • Vilnius, Lithuania, LT-08661
        • Oncology Institute of Vilnius University
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Floriana, Malta, VLT 14
        • Sir Paul Boffa Hospital
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Núcleo de Especialidades Oncológicas
      • Amstelveen, Netherlands, 1186 AM
        • Ziekenhuis Amstelland
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre ZH
      • Breda, Netherlands, 4819 EV
        • Amphia Ziekenhuis - Interne Geneeskunde
      • Den Haag, Netherlands, 2545 CH
        • Haga ziekenhuis
      • Eindhoven, Netherlands, 5631 BM
        • Maxima Medisch Centrum
      • Schiedam, Netherlands, 3118 JH
        • Vlietland ziekenhuis
      • Sittard-Geleen, Netherlands, 6162 BG
        • Orbis Medisch Centrum
      • Auckland, New Zealand, 1023
        • Auckland Hospital
      • Skopje, North Macedonia, 1000
        • University Clinic For Radiotherapy and Oncology
    • Lima
      • Surco, Lima, Peru, 33
        • Clínica Vista Alegre / Unidad de Investigacion
      • Bialystok, Poland, 15027
        • Bialostockie Centrum Onkologii im. M. Sklodowskiej- Curie w Bialymstoku
      • Bydgoszcz, Poland, 85-796
        • Centrum Onkologii im. prof. Franciszka Łukaszczyka
      • Bydgoszcz, Poland, 85796
        • Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
      • Gdansk, Poland, 80952
        • Uniwersyteckie Centrum Kliniczne w Gdańsku
      • Gdynia, Poland, 81519
        • Szpital Morski im. PCK Gdynskie Centrum Onkologii Oddzial Chemioterapii
      • Jelenia Gora, Poland, 58506
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewodzki Oddzial
      • Krakow, Poland, 31531
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w
      • Olsztyn, Poland, 10228
        • Zaklad Opieki Zdrowotnej MSWiA z Warminsko - Mazurskim Centrum Onkologii w
      • Olsztyn, Poland, 10513
        • Olsztyński Ośrodek Onkologiczny Kopernik sp. z o.o.
      • Tarnow, Poland, 33100
        • Szpital Wojewodzki im. Sw. Lukasza Samodzielny Publiczny Zaklad Opieki
      • Warszawa, Poland, 04125
        • Centrum Medyczne Ostrobramska Niepubliczny Zaklad Opieki Zdrowotnej "Magodent"
      • Bucuresti, Romania, 050098
        • Spitalul Universitar de Urgenta Bucuresti
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta"
    • Dolj
      • Craiova, Dolj, Romania, 200385
        • SC Oncolab S.R.L.
      • Belgrade, Serbia, 11000
        • Institute of Oncology and Radiology of Serbia
      • Nis, Serbia, 18000
        • Clinical Centre Nis
      • Singapore, Singapore, 169610
        • National Cancer Centre Singapore
      • Bratislava, Slovakia, 81250
        • Interna onkologicka klinika
      • Kosice, Slovakia, 04191
        • Oddelenie radioterapie a onkologie
      • Poprad, Slovakia, 05801
        • Poliklinika ADUS
      • A Coruna, Spain, 15009
        • Centro Oncológico de Galicia
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d´Hebron
      • Caceres, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta Del Mar
      • Castellon, Spain, 12002
        • Consorcio Hospitalario Provincial de Castellón
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Girona, Spain, 17007
        • ICO de Girona - Hospital Universitario de Girona Dr. Josep Trueta
      • Guadalajara, Spain, 19002
        • Hospital Universitario de Guadalajara
      • Jaen, Spain, 23007
        • Complejo Hospitalario de Jaén
      • Las Palmas de Gran Canaria, Spain, 35016
        • Hospital Universitario Insular de Gran Canaria
      • Lleida, Spain, 25198
        • Hospital Universitari Arnau de Vilanova de Lleida
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro. Centro Integral Oncologico Clara Campal
      • Malaga, Spain, 14004
        • Hospital Clinico Universitario Virgen de la Victoria
      • Santa Cruz de Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Toledo, Spain, 45004
        • Hospital Virgen De La Salud
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Spain, 46010
        • Fundacion Instituto Valenciano de Oncologia
      • Zamora, Spain, 49021
        • Hospital Provincial de Zamora
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
      • Torrevieja, Alicante, Spain, 03186
        • Hospital de Torrevieja
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitari Germans Trias i Pujol
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • ICO de Barcelona - Hospital Duran i Reynals, Hospitalet de Llobregat Consorci Sanitari de Terrassa
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Sanitari de Terrassa
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Mutua De Terrassa
    • Huesca
      • Barbastro, Huesca, Spain, 22300
        • Hospital de Barbastro
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07010
        • Hospital Universitari Son Espases
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Hospital Universitario Fundacion de Alcorcon
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Puerta de Hierro-Majadahonda
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
      • Lund, Sweden, 22185
        • Onkologiska Kliniken
      • Lund, Sweden, 22185
        • Skanes Onkologiska Kliniken
      • Aarau, Switzerland, 5000
        • Hirslanden Medical Center Tumor Center
      • Baden, Switzerland, 5404
        • Kantonsspital Baden
      • Olten, Switzerland, 4600
        • Kantonsspital Olten-Medizinische Onkologie
      • Thun, Switzerland, 3600
        • Spital STS AG
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kwei-Shan, Taoyuan, Taiwan, 333
        • Chang Gung medical Foundation, Linkou Branch
      • Taipei TOC, Taiwan, 100
        • National Taiwan University Hospital
      • Besevler/Ankara, Turkey, 06500
        • Gazi Universitesi Tip Fakultesi
      • Bornova/Izmir, Turkey, 35100
        • Ege Universitesi Tip Fakultesi
      • Capa/Istanbul, Turkey, 34390
        • Istanbul Universitesi Istanbul Tip Fakultesi
      • Cerrahpasa/Istanbul, Turkey, 34098
        • Istanbul Universitesi Cerrahpasa Tip Fakultesi, Ic Hastaliklari Anabilim Dali
      • Demetevler/Ankara, Turkey, 06200
        • Dr. Abdurrahman Yurtaslan Onkoloji Egitim ve Arastirma Hastanesi
      • Gorukle/Bursa, Turkey, 16059
        • Uludag Universitesi Tip Fakultesi
      • Inciralti/Izmir, Turkey, 35340
        • Dokuz Eylul Universitesi Tip Fakultesi
      • Istanbul, Turkey, 34890
        • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
      • Sehitkamil/Gaziantep, Turkey, 27310
        • Gaziantep Universitesi
      • Sihhiye/Ankara, Turkey, 06100
        • Hacettepe Universitesi Tip Fakultesi
      • Leeds, United Kingdom, LS9 7TF
        • St James's University Hospital
      • Leicester, United Kingdom, LE1 5WW
        • University Hospitals of Leicester
      • London, United Kingdom, SE1 9RT
        • Guy's Hospital
      • London, United Kingdom, EC1A 7BE
        • St. Bartholomew's Hospital
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital, Department of Medical Oncology
      • Manchester, United Kingdom, M20 4BX
        • Christie Hospital
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk & Norwich University Hospitals
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital
      • Sheffield, United Kingdom, S10 2SJ
        • Weston Park Hospital
      • Swansea, United Kingdom, SA2-8QA
        • Singleton Hospital
      • Westcliff-on-Sea, United Kingdom, SS0 0RY
        • Southend University Hospital
    • Denbighshire
      • Rhyl, Denbighshire, United Kingdom, LL18 5UJ
        • Betsi Cadwaladr University Health Board
    • Staffs
      • Burton-on-Trent, Staffs, United Kingdom, DE13 0RB
        • Queens Hospital
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Anniston Oncology
      • Birmingham, Alabama, United States, 35205
        • Birmingham Hematology and Oncology Associates, LLC
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Oncology Associates, PC - HAL
      • Sedona, Arizona, United States, 86336
        • Arizona Oncology Associates, Pc - Nahoa
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
      • Tucson, Arizona, United States, 85704-7891
        • Arizona Oncology Associates
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Northeast Arkansas Clinic
    • California
      • Beverly Hills, California, United States, 90211
        • Cedars-Sinai Medical Group
      • Gilroy, California, United States, 95020
        • Ronald Yanagihara, M.D.
      • Glendale, California, United States, 91206
        • Glendale Adventist Medical Center Cancer Services
      • Greenbrae, California, United States, 94904
        • California Cancer Care
      • Highland, California, United States, 92346
        • Beaver Medical Group, L.P.
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Long Beach, California, United States, 90806
        • Breastlink Medical Group
      • Mission Hills, California, United States, 91345
        • Facey Medical Group
      • Newport Beach, California, United States, 92663
        • Gynecologic Oncology Associates
      • Oxnard, California, United States, 93030
        • Ventura County Hematology-Oncology Specialists
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group, Inc
      • San Francisco, California, United States, 94115
        • Helen Diller Family University of California San Francisco Comprehensive Cancer Center
      • San Francisco, California, United States, 94115
        • San Francisco Oncology Associates
      • Santa Rosa, California, United States, 95403
        • Redwood Regional Medical Group
      • Soquel, California, United States, 95073
        • The Cancer Prevention and Treatment Center
    • Connecticut
      • Southington, Connecticut, United States, 06489
        • Cancer Center of Central Connecticut
      • Stamford, Connecticut, United States, 06902
        • Hematology Oncology, PC
      • Torrington, Connecticut, United States, 06790
        • Connecticut Oncology and Hematology
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute at Washington Hospital Center
    • Florida
      • Aventura, Florida, United States, 33180
        • Innovative Medical Research of South Florida, Inc.
      • Boynton Beach, Florida, United States, 33426
        • University Cancer Institute, LLC
      • Deerfield Beach, Florida, United States, 33064
        • North Broward Medical Center
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center
      • Gainesville, Florida, United States, 32605
        • Florida Cancer Specialists and Research Institute
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Cancer Center
      • Loxahatchee Groves, Florida, United States, 33470
        • Hematology Oncology Associates
      • Ocala, Florida, United States, 34471
        • Florida Cancer Affiliates - Ocala
      • Orange City, Florida, United States, 32763-8316
        • Mid-Florida Hematology & Oncology Centers, PA
      • Orlando, Florida, United States, 32806
        • Cancer Centers of Florida
      • Orlando, Florida, United States, 32806
        • M.D. Anderson Cancer Center Orlando
      • Plantation, Florida, United States, 33324
        • Florida Cancer Research Institute
      • Port Saint Lucie, Florida, United States, 34592
        • Hematology Oncology Associates of Treasure Coast
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists, P.L.
      • Tamarac, Florida, United States, 33321
        • Oncology and Hematology of West Broward
      • Zephyrhills, Florida, United States, 33542
        • Florida Medical Clinic, P.A.
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Cancer Center
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute
      • Augusta, Georgia, United States, 30909
        • Augusta Oncology Associates (ACORN), P.C.
      • Fort Gordon, Georgia, United States, 30905-5650
        • Dwight David Eisenhower Army Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813-3083
        • Straub Clinic & Hospital
    • Idaho
      • Pocatello, Idaho, United States, 83201
        • Portneuf Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois, Decatur Memorial Hospital Clinical Research
      • Joliet, Illinois, United States, 60432
        • Midwest Center for Hematology/Oncology
      • Moline, Illinois, United States, 61265
        • Medical Arts Associates, Ltd
      • Niles, Illinois, United States, 60714
        • Advocate Medical Group
      • Niles, Illinois, United States, 60714
        • Cancer Care & Hematology Specialists of Chicagoland
      • Quincy, Illinois, United States, 62301
        • Quincy Medical Group, Cancer Center at Blessing Hospital
      • Skokie, Illinois, United States, 60076
        • North Shore Cancer Research Associates
      • Skokie, Illinois, United States, 60076
        • Orchard Healthcare Research, Inc.
      • Skokie, Illinois, United States, 60076
        • Orchard Research, LLC
      • Springfield, Illinois, United States, 62702
        • Simmons Cancer Institute
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic, LLP
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Central Indiana Cancer Centers
      • Indianapolis, Indiana, United States, 46260-2082
        • Hematology Oncology Of Indiana
      • Munster, Indiana, United States, 46321
        • Community Hospital
    • Kentucky
      • Ashland, Kentucky, United States, 41101-7016
        • Ashland-Bellefonte Cancer Center
      • Paducah, Kentucky, United States, 42001
        • Purchase Cancer Group
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hematology-Oncology Clinic
      • Marrero, Louisiana, United States, 70072
        • Crescent City Research Consortium, LLC
    • Maine
      • Lewiston, Maine, United States, 04240
        • Central Maine Healthcare Corp
      • Portland, Maine, United States, 04102
        • Mercy Hospital Oncology/Hematology Center
      • York, Maine, United States, 03909
        • York Hospital Oncology Treatment Center
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Medical Oncology & Hematology Mercy Medical Center
      • Baltimore, Maryland, United States, 21237
        • Harry and Jeanette Weinberg Cancer Center
      • Westminster, Maryland, United States, 21157
        • Alliance Hematology Oncology, PA Carroll County Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital - Gillette Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201-2013
        • Barbara Ann Karmanos Cancer Institute
      • Grand Rapids, Michigan, United States, 49503
        • Cancer and Hematology Centers of Western Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Medical Specialty Associates
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hematology/Oncology
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology, Pa
      • Saint Louis Park, Minnesota, United States, 55426
        • Park Nicollet Institute
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Hematology and Oncology Associates, Ltd.
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Capitol Comprehensive Cancer Care Clinic
      • Saint Joseph, Missouri, United States, 64507
        • St. Joseph's Oncology
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine Siteman Cancer Center
      • Springfield, Missouri, United States, 65807
        • Mercy Medical Research Institute
    • Montana
      • Missoula, Montana, United States, 59802
        • Montana Cancer Specialists
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Hematology & Oncology Consultants, PC
      • North Platte, Nebraska, United States, 69101
        • Great Plains Regional Medical Center
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • The Center for Cancer and Hematologic Disease
      • Elizabeth, New Jersey, United States, 07207
        • Trinitas Comprehensive Cancer Center
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Health Care System
      • Morristown, New Jersey, United States, 07960
        • Summit Medical Group
      • Mountain Lakes, New Jersey, United States, 07046
        • Oncology and Hematology Specialist
      • Neptune, New Jersey, United States, 07754
        • Jersey Shore University Medical Center
      • Paramus, New Jersey, United States, 07652
        • The Valley Hospital, Luckow Pavilion
      • Voorhees, New Jersey, United States, 08043-4689
        • Cooper University Hospital
    • New York
      • Bronx, New York, United States, 10469
        • Eastchester Center for Cancer Care
      • Lake Success, New York, United States, 11042
        • ProHEALTH Care Associates
      • New York, New York, United States, 10016
        • NYU Clinical Cancer Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center, Herbert Irving Comprehensive Cancer Center
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • NorthEast Oncology Associates Carolinas Medical Center NorthEast
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center Medical Oncology
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Hematology Oncology Associates Cancer Centers of North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Hanover Medical Specialists, PA
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital Cancer Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals, Cleveland Medical Center
      • Middletown, Ohio, United States, 45042
        • Signal Point Hematology/Oncology, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Physicians Of Oklahoma
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Corvallis, Oregon, United States, 97330
        • Samaritan Hematology & Oncology Consultants
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97213
        • Northwest Cancer Specialist, P.C.
      • Portland, Oregon, United States, 97213
        • Providence Cancer Center Oncology and Hematology Care - Westside
      • Portland, Oregon, United States, 97227-1110
        • Kaiser Permanente Northwest Region Oncology Hematology
      • Springfield, Oregon, United States, 97477
        • Willamette Valley Cancer Institute and Research Center
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Oncology-Hematology of Lehigh Valley, Pc
      • Gettysburg, Pennsylvania, United States, 17325
        • Gettysburg Cancer Center
      • Harrisburg, Pennsylvania, United States, 17109
        • Pinnacle Health Cancer Center Community Campus
      • Monongahela, Pennsylvania, United States, 15063
        • Sweeney-Melenyser Pavillion
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Perelman Center for Advanced Medicine
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Cancer Center
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Clinic, Limited
      • Willow Grove, Pennsylvania, United States, 19090-1137
        • Abington Hematology Oncology Associates, Inc
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Pawtuket Memorial Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Charleston Hematology Oncology Associates, PA
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Hollings Cancer Center
      • Columbia, South Carolina, United States, 29203
        • Francisco Gonzalez MD PA
      • Florence, South Carolina, United States, 29506
        • McLeod Oncology and Hematology Associates
      • Hilton Head Island, South Carolina, United States, 29926
        • South Carolina Cancer Specialists
      • Sumter, South Carolina, United States, 29150
        • Santee Hematology Oncology
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Medical Oncology and Hematology - Avera Cancer Institute
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • University Hematology/Oncology Associates PLLC
      • Cookeville, Tennessee, United States, 38501
        • Cookeville Regional Cancer Center
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic, PC
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37203
        • Nashville Breast Center
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Oncology, P.A.
      • Bedford, Texas, United States, 76022
        • Texas Oncology, P.A.
      • Corpus Christi, Texas, United States, 78404
        • Coastal Bend Cancer Center
      • Corpus Christi, Texas, United States, 78405
        • South Texas Institute of Cancer
      • Corpus Christi, Texas, United States, 78412
        • Cancer Specialists of South Texas, P.A.
      • Dallas, Texas, United States, 75246
        • Texas Oncology - Baylor Charles A. Sammons Cancer Center
      • Dallas, Texas, United States, 75230
        • Center for Oncology Research
      • Dallas, Texas, United States, 75231-4400
        • Texas Oncology, P.A.
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center Simmons Cancer Center
      • Denton, Texas, United States, 76210
        • Texas Oncology, P.A.
      • El Paso, Texas, United States, 79902
        • El Paso Cancer Treatment Center - West
      • El Paso, Texas, United States, 79912
        • Center for Integrative Cancer Medicine, PA
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology
      • Garland, Texas, United States, 75042
        • Texas Oncology, P.A.
      • Houston, Texas, United States, 77024
        • Texas Oncology - Memorial City
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Breast Center
      • Houston, Texas, United States, 77055
        • Medicus Alliance Clinical Research Org., Inc.
      • Houston, Texas, United States, 77082
        • Jabboury Foundation for Cancer Research, Inc.
      • Paris, Texas, United States, 75460
        • Texas Oncology, P.A.
      • San Antonio, Texas, United States, 78217
        • Cancer Care Centers of South Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Oncology & Hematology
      • Sugar Land, Texas, United States, 77479
        • Texas Oncology P.A.
      • Tyler, Texas, United States, 75702
        • Texas Oncology
      • Tyler, Texas, United States, 75701
        • East Texas Medical Center Cancer Institute
      • Waco, Texas, United States, 76712
        • Texas Oncology Cancer Care and Research Center
    • Utah
      • Ogden, Utah, United States, 84403
        • North Utah Associates
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Southwestern Vermont Regional Cancer Center
      • Rutland, Vermont, United States, 05701
        • Rutland Regional Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
    • Washington
      • Kirkland, Washington, United States, 98034
        • Cascade Cancer Center
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest-North
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties PLLC
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Mary Babb Randolph Cancer Center
      • Wheeling, West Virginia, United States, 26003
        • Wheeling Hospital
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54311
        • Aurora BayCare Medical Center
      • Racine, Wisconsin, United States, 53405
        • Wheaton Franciscan Cancer Care-All Saints

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
  • Been treated for early breast cancer with standard of care duration of trastuzumab.
  • Could have been treated neoadjuvantly but have not reached pathologic complete response.

Exclusion Criteria:

  • Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
  • History of heart disease.
  • Corrected QT (QTc) interval >0.45 seconds
  • History of gastrointestinal disease with diarrhea as the major symptom.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neratinib
240 mg orally daily for one year
Other Names:
  • HKI-272
  • Nerlynx
Placebo Comparator: Placebo
orally daily for one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
Time Frame: From randomization until time of event up to 2 years
Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
From randomization until time of event up to 2 years
Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms
Time Frame: From randomization until time of event up to 2 years
From randomization until time of event up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Randomization until death due to any cause (up to 119 Months)
OS was defined as the time from randomization to death due to any cause, censored at the last date known alive.
Randomization until death due to any cause (up to 119 Months)
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2
Time Frame: From randomization until time of event up to 2 years
Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.
From randomization until time of event up to 2 years
Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms
Time Frame: From randomization until time of event up to 2 years
From randomization until time of event up to 2 years
Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2
Time Frame: From randomization until time of event up to 2 years
Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.
From randomization until time of event up to 2 years
Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms
Time Frame: From randomization until time of event up to 2 years
From randomization until time of event up to 2 years
Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2
Time Frame: From randomization until time of event up to 2 years
Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.
From randomization until time of event up to 2 years
Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms
Time Frame: From randomization until time of event up to 2 years
From randomization until time of event up to 2 years
Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2
Time Frame: From randomization until time of event up to 2 years
CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence.
From randomization until time of event up to 2 years
Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2
Time Frame: From randomization until time of event up to 2 years
Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).
From randomization until time of event up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 5
Time Frame: From randomization until time of event up to 5 years
Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
From randomization until time of event up to 5 years
Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 5 by Treatment Arms
Time Frame: From randomization until time of event up to 5 years
From randomization until time of event up to 5 years
Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 5
Time Frame: From randomization until time of event up to 5 years
Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.
From randomization until time of event up to 5 years
Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 5
Time Frame: From randomization until time of event up to 5 years
Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.
From randomization until time of event up to 5 years
Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 5
Time Frame: From randomization until time of event up to 5 years
Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.
From randomization until time of event up to 5 years
Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 5
Time Frame: From randomization until time of event up to 5 years
Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).
From randomization until time of event up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2009

Primary Completion (Actual)

August 21, 2014

Study Completion (Actual)

October 4, 2019

Study Registration Dates

First Submitted

April 8, 2009

First Submitted That Met QC Criteria

April 8, 2009

First Posted (Estimate)

April 9, 2009

Study Record Updates

Last Update Posted (Actual)

June 11, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

IPD Sharing Time Frame

Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.

IPD Sharing Access Criteria

Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.

Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on placebo

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